1. Introduction.
The following description includes information that may be useful in understanding the present invention. It is not an admission that any such information is prior art, or relevant, to the presently claimed inventions, or that any publication specifically or implicitly referenced is prior art.
2. Background.
Modern medical practice frequently involves using catheters to introduce fluids and medications directly into a patient's vasculature. Examples include peripheral intravenous catheters (PIVCs) and central venous catheters (CVCs). Often, it is necessary to maintain such catheterization over an extended period during a patient's treatment, particularly when the patient is hospitalized. In order to keep a catheter (or other medical line) properly positioned for as long as needed, the catheter (or other medical line) is typically secured to the patient in a variety of ways. Historically this involved taping the catheter or medical line to the patient.
Securing catheters to patient using tape, however, has several drawbacks. First, the use of tape to secure a catheter can retain dirt or other contaminants at or near the catheter insertion site, potentially leading to infection or other complications. Indeed, numerous clinical studies have implicated improperly secured catheters in a wide range of complications, including catheter-related blood stream infections (CRBSI), of which there are about 80,000 annually in the U.S. alone. Second, tape often fails to limit catheter movement in one or more directions, and thus can contribute to motion-related complications such as bruising, phlebitis, extravasation, infiltration, and catheter migration, which can lead to catheter dislodgement or disconnection. Third, tape removal can itself cause undesired catheter movement. Fourth, tape must periodically be changed, often daily. The frequent removal and reapplication of adhesive tape can irritate a patient's skin, as well as lead to the build up of adhesive residue on the outer surface of the catheter (or other medical line). Such adhesive residue not only makes the catheter (or other medical line) stickier and more difficult for healthcare providers to handle, it can also result in contaminants (including pathogens) adhering to the catheter itself, increasing the likelihood of infection, either at the skin surface or internally. Fifth, tape securement can allow medical lines attached to a catheter to flex or kink, which can lead to clinical complications.
As a result of these drawbacks, other approaches to securing catheters and medical lines have been sought. One such solution is reported in U.S. Pat. Nos. 7,014,627 and 7,799,001. However, such devices themselves have many drawbacks, including high unit cost, the use of hard plastic components (which can lead to patient discomfort), requirements for bulky packaging because of the device's awkward three-dimensional shape, difficulty in using such devices, and the need for hospitals to stock large inventories because individual devices are not adaptable to fit the wide range of different catheters and medical articles routinely in use today. For these reasons a significant unmet need still exists for inexpensive, low-profile, easy-to-use medical article securement devices.
3. Definitions
Before describing the instant invention in detail, several terms used in the context of the present invention will be defined. In addition to these terms, others are defined elsewhere in the specification, as necessary. Unless otherwise expressly defined herein, terms of art used in this specification will have their art-recognized meanings.
The term “adaptive” refers a device's or structure's ability to adapt and substantially conform to the exterior shape and/or contours of another article, including articles having different exterior dimensions and shapes.
A “medical article” refers to catheters, catheter hubs, medical line connector fittings, luer access devices, medical lines (e.g., tubing intended to deliver fluids to a patient), and the like.
A “patentable” composition, process, machine, or article of manufacture according to the invention means that the subject matter at issue satisfies all statutory requirements for patentability at the time the analysis is performed. For example, with regard to novelty, non-obviousness, or the like, if later investigation reveals that one or more claims encompass one or more embodiments that would negate novelty, non-obviousness, etc., the claim(s), being limited by definition to “patentable” embodiments, specifically excludes the unpatentable embodiment(s). Also, the claims appended hereto are to be interpreted both to provide the broadest reasonable scope, as well as to preserve their validity. Furthermore, if one or more of the statutory requirements for patentability are amended or if the standards change for assessing whether a particular statutory requirement for patentability is satisfied from the time this application is filed or issues as a patent to a time the validity of one or more of the appended claims is questioned, the claims are to be interpreted in a way that (1) preserves their validity and (2) provides the broadest reasonable interpretation under the circumstances.
A “plurality” means more than one.